510(k) K982668

PHORESOR II,MODEL PM900 by Iomed, Inc. — Product Code EGJ

K982668 is an FDA 510(k) premarket notification submitted by Iomed, Inc. for the device "PHORESOR II,MODEL PM900". The FDA issued a decision of Substantially Equivalent on March 2, 1999. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Iomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1999
Date Received
July 31, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type